Data privacy protection in scientific publications: process implementation at a pharmaceutical company.

BACKGROUND: Sharing anonymized/de-identified clinical trial data and publishing research outcomes in scientific journals, or presenting them at conferences, is key to data-driven scientific exchange. However, when data from scientific publications are linked to other publicly available personal information, the risk of reidentification of trial participants increases, raising privacy concerns. Therefore, we defined a set of criteria allowing us to determine and minimize the risk of data reidentification. We also implemented a review process at Takeda for clinical publications prior to submission for publication in journals or presentation at medical conferences. METHODS: Abstracts, manuscripts, posters, and oral presentations containing study participant information were reviewed and the potential impact on study participant privacy was assessed. Our focus was on direct (participant ID, initials) and indirect identifiers, such as sex, age or geographical indicators in rare disease studies or studies with small sample size treatment groups. Risk minimization was sought using a generalized presentation of identifier-relevant information and decision-making on data sharing for further research. Additional risk identification was performed based on study participant/personnel parameters present in materials destined for the public domain. The potential for participant/personnel identification was then calculated to facilitate presentation of meaningful but de-identified information. RESULTS: The potential for reidentification was calculated using a risk ratio of the exposed versus available individuals, with a value above the threshold of 0.09 deemed an unacceptable level of reidentification risk. We found that in 13% of Takeda clinical trial publications reviewed, either individuals could potentially be reidentified (despite the use of anonymized data sets) or inappropriate data sharing plans could pose a data privacy risk to study participants. In 1/110 abstracts, 58/275 manuscripts, 5/87 posters and 3/58 presentations, changes were necessary due to data privacy concerns/rules. Despite the implementation of risk-minimization measures prior to release, direct and indirect identifiers were found in 11% and 34% of the analysed documents, respectively. CONCLUSIONS: Risk minimization using de-identification of clinical trial data presented in scientific publications and controlled data sharing conditions improved privacy protection for study participants. Our results also suggest that additional safeguards should be implemented to ensure that higher data privacy standards are met.

The economic burden of pulmonary arterial hypertension (PAH) in the US on payers and patients.

BACKGROUND: Pulmonary arterial hypertension (PAH) is a rare condition that can ultimately lead to right heart failure and death. In this study we estimated the health care costs and resource utilization associated with PAH in a large US managed care health plan. METHODS: Subjects with claims-based evidence of PAH from 1/1/2004 to 6/30/2010 (identification period) were selected. To be included in the final PAH study sample, subjects were required to have ≥2 claims with a primary PH diagnosis; ≥2 claims with a PAH related-diagnosis (connective tissue diseases, congenital heart diseases, portal hypertension); and ≥1 claim with evidence of a PAH-indicated medication. The earliest date of a claim with evidence of PAH-indicated medication during the identification period was set as the index date. Health care costs and resource utilization were compared between an annualized baseline period and a 12 month follow-up period. RESULTS: 504 PAH subjects were selected for the final study cohort. Estimated average total health care costs were approximately 16% lower in the follow-up period compared to the baseline period (follow-up costs = $98,243 [SD = 110,615] vs. baseline costs = $116,681 [SD = 368,094], p < 0.001), but substantively high in each period relative to costs reported for other chronic diseases. Pharmacy costs were significantly higher in the follow-up period vs. the baseline period, ($38,514 [SD = 34,817] vs. $6,440 [SD = 12,186], p < 0.001) but medical costs were significantly lower in the follow-up vs. baseline ($59,729 [SD = 106,683] vs. $110,241 [SD = 368,725], p < 0.001). These costs were mirrored in health-care resource utilization estimates. The average counts of ambulatory visits and inpatient stays were lower in the follow-up vs. the baseline (both p < 0.001). Results varied in exploratory analyses when less restrictive subject identification algorithms were used. CONCLUSIONS: Subjects with evidence of PAH had substantively high health care costs. Medical costs appeared to decrease following PAH medication use, but with a concomitant increase in pharmacy costs.

Drug utilization patterns and cardiovascular outcomes in elderly patients newly initiated on atorvastatin or simvastatin.

BACKGROUND: Hydroxymethylglutaryl coenzyme-A reductase inhibitors simvastatin and atorvastatin are effective at lowering LDL-C levels and reducing the risk of cardiovascular (CV) events. OBJECTIVE: The objective of this study was to examine differences in drug utilization and CV event risk among elderly patients newly initiated on simvastatin versus atorvastatin. METHODS: This was a retrospective analysis using pharmacy and medical claims from a US health plan database. Enrollees aged ≥65 years, newly initiated on simvastatin or atorvastatin (index drugs) from July 1, 2006 to November 30, 2008 were identified for study inclusion. Patients were excluded if they had any prescriptions for clopidogrel, nitrates, or other dyslipidemia medication, or any CV events before index drug initiation. Adherence was calculated by proportion of days covered with index medication. CV events (myocardial infarction, ischemic heart disease, cerebrovascular disease, peripheral vascular disease, aortic aneurysm, revascularization, or heart failure) were identified from medical claims. RESULTS: There were 11,470 atorvastatin initiators and 20,132 simvastatin initiators identified. Mean age of these patients was 72 years; 40% were male; nearly half had hypertension; and more than a quarter had diabetes. The majority of statin therapy (77%) was prescribed by primary care physicians. Forty-nine percent of atorvastatin patients were initiated on a 10 mg-dose and 61% of simvastatin patients on 5-, 10-, or 20-mg doses. A larger percentage of patients in the simvastatin cohort were adherent to index therapy than patients in the atorvastatin cohort (43% vs 36%, respectively). Multivariate regression adjusting for patient characteristics revealed no significant difference in CV events between patients receiving atorvastatin versus simvastatin. CONCLUSIONS: In this study of elderly statin patients without recent evidence of CV events, the majority of patients started on low-dose therapy and did not achieve sufficient adherence. After controlling for patient and clinical characteristics, no statistically significant difference in risk of CV event was observed based on initiation with atorvastatin versus simvastatin.

Tinkering with the fly genome.

A new strategy provides a leap forward in making transgenic flies.

Good enhancer hunting.

A new strategy allows identification of enhancers in the human genome on a large scale.

Adult stem cells come up short.

New research demonstrates that terminally differentiated cells are more efficient than adult stem cells for cloning.

siRNAs meet their match.

A new study addresses how to design highly specific small interfering RNAs (siRNAs) capable of distinguishing between similar variants of the same gene.